SOFT PLUG Extended Duration 180-T Tapered Plug - 40 pk

Manufacturer Item #: 6210

About the Product

The OASIS Medical SOFT PLUG Extended Duration 180-T Tapered Canalicular Plugs is a medium term plug (up to 6 months) designed to be inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system. This residency time falls between the absorbable collagen plugs, which are completely absorbed after several days, and the permanent intracanalicular plug, which is designed to remain in the canaliculum indefinitely.

SOFT PLUG Extended Duration 180-T Tapered Canalicular Plugs are made from an absorbable synthetic material called polydioxanone. They are .25 diameter at tapered point, .6 at widest point, 2mm length. The plugs are supplied sterile, two plugs per package in foam holders, so that a plug can be placed into each canaliculus.

Indications for Use: The SOFT PLUG® Extended Duration 180 Tapered Canalicular Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:

• Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
• Temporarily enhance the efficacy of topical medications or ocular lubricants,
• Temporarily treat contact lens intolerance secondary to dry eye,
• Temporarily treat dry eye after ocular surgery, and
• Determine the potential effectiveness of permanent occlusion.

Specifications

• 0.25mm diameter at tapered point, 0.6mm at widest point
• Length: 2mm
• Sterile, insert with forceps
• Absorbable punctual plugs
• Last up to 6 months
• 40 plugs per box
• For pre and post-surgical use

How to Use

Insertion: Prior to insertion, inspect the patient’s punctum to determine the appropriate diameter plug to use. Punctal sizing instruments are available from OASIS Medical. It is recommended that the 0.6mm punctal gauge be used to determine if the tapered canalicular plug will fit through a smaller opening.

Apply a topical anesthetic to the eyelid prior to insertion of the plug.

Open the sterile Tyvek and foil pouches and remove the appropriate diameter plug from the foam holder using sterile jeweler’s forceps.

A small amount of lubricant may be used on the plug or punctum in order to facilitate insertion across the punctum.

Insert the plug part way through the punctal opening while grasping the plug with the forceps. Release the plug and use the tip of the forceps to push the plug the rest of the way through the punctal opening and into the canaliculus.

Following insertion, inspect the punctal opening to ensure the plug is below the punctal opening.

Warnings

Contraindications: The SOFT PLUG® Extended Duration 180 Tapered Canalicular Plugs are contraindicated for:

• Patients with known sensitivities or allergies to polydioxanone,
• Patients who are experiencing epiphora, canaliculitis, infectious conjunctivitis, or dacryocystitis with mucopurulent discharge.

Warnings: DO NOT USE IF PACKAGE IS OPEN OR DAMAGED. Sterility may be compromised or moisture may shorten the shelf life of the plug.

DO NOT REUSE. This is a single use, disposable, device that cannot be properly cleaned and re-sterilized. Canalicular plugs may enhance the effect of ocular medications used on the eye. Depending on the type of medications being used, dosage may need to be reduced accordingly.

Care should be used not to tear the punctum or puncture the canaliculus while inserting the plug. Perforations may cause pain and increase the risk of infection. If perforation occurs, delay the insertion of the plug until the wound heals.

If the patient experiences irritation, infection, or epiphora after insertion, the plug should be removed. Saline irrigation may be used to expel the plug through the lacrimal drainage system into the nose or throat.

Cautions: Federal law (USA) restricts this device to sale by or on the order of a physician.

The Summary of Safety and Clinical Performance (SSCP) is available to the public via European database – EUDAMED.

Potential Risks / Adverse Reactions of Implantation:

• Tearing of the punctum or puncture of the canaliculus during insertion,
• Infection related to insertion,
• Excessive epiphora,
• Infection related to contamination trapped in the canaliculus due to insertion of a plug,
• Allergic reaction to polydioxanone resulting in irritation, itching, or swelling,
• Possible need to surgically remove a plug that cannot be flushed out of the canaliculus.

Storage

Store between 0°C and 35°C (32°F to 95°F). Keep dry.